Unique ID issued by UMIN | UMIN000051280 |
---|---|
Receipt number | R000057995 |
Scientific Title | Effect of mental training web application for subthreshold insomnia, subthreshold depression and subthreshold panic Six arms randomized controlled trial |
Date of disclosure of the study information | 2023/06/07 |
Last modified on | 2023/06/07 14:47:50 |
Effect of mental training web application for subthreshold insomnia, subthreshold depression and subthreshold panic
Six arms randomized controlled trial
Validation of mental training apps for subthreshold symptoms
Effect of mental training web application for subthreshold insomnia, subthreshold depression and subthreshold panic
Six arms randomized controlled trial
subthreshold- MENTORE App.
Japan |
subthreshold insomnia, subthreshold depression, subthreshold panic
Not applicable |
Others
NO
To explore effectivity of mental training web app for subthreshold insomnia, subthreshold depression and subthreshold panic on six arms randomized controlled trial.
Safety,Efficacy
subthreshold insomnia: amount of change PSQI(Pittsburgh Sleep Quality Index) from 0 week to 4 weeks.
subthreshold depression: amount of change CES-D(Center for Epidemiologic Studies Depression Scale ) from 0 week to 4 weeks.
subthreshold insomnia: amount of change PAS(Panic and Agoraphobia Scale)from 0 week to 4 weeks.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Placebo
6
Educational,Counseling,Training
Behavior,custom | Other |
Intervention 1/ subthreshold insomnia: to do insomnia program of MENTORE app once a week, 4 time in all(4 weeks intervention)
Control 2/ Siamese app once a day log in, 4weeks
subthreshold depression: to do anxiety and depression program of MENTORE app once a week, 4 time in all(4 weeks intervention)
Control 4/ Siamese app once a day log in, 4weeks
subthreshold insomnia: to do panic program of MENTORE app once a week, 4 time in all(4 weeks intervention)
Control 6/ Siamese app once a day log in, 4weeks
18 | years-old | <= |
70 | years-old | >= |
Male and Female
1 18 to 70 years old
2 People who do not go to the hospital due to mental or physical illness
3 no suicidal ideation
4 have an internet environment
5 Japanese speaker and persons can be online consent
6 Apply to below A to C
A subthreshold insomnia
PSQi6 or more and Insomnia symptoms less than 3 month
B subthreshold depression
Does not meet PHQ9 diagnostic criteria for depression and CESD 16 or more
and depression symptoms less than 2 years
C subthreshold panic
PAS 9 or more and panic symptoms less than 1 month
note that
If subthreshold panic overlaps, it is classified as a panic group, and if subthreshold insomnia and subthreshold depression overlap, it is classified as a depression group
1 People who have been diagnosed with mental illness including sleep disorder, depression, panic disorder
2 PHQ9 section 2 score 2 or more
3 diagnosed with a serious progressive physical disease such as cancer or heart failure and are currently visiting a hospital
4 undergoing drug therapy for mental or physical symptoms however, use of OTC drugs and supplements purchased at pharmacies is not excluded
5 suspected of having sleep apnea syndrome or restless legs syndrome
6 Night shift workers
600
1st name | Eiji |
Middle name | |
Last name | Shimizu |
Chiba University Graduate School of Medicine
Department of Cognitive Behavioral Physiology
2608670
1-8-1 inohana chuo-ku chiba city Chiba
043-226-2027
eiji@faculty.chiba-u.jp
1st name | Kayoko |
Middle name | |
Last name | Taguchi |
Chiba University
Research Center for Child Mental Developmen
2608670
1-8-1 inohana chuo-ku chiba city Chiba
043-226-2027
k.taguchi@chiba-u.jp
Chiba University
Japan Science and Technology agency
Japanese Governmental office
Institutional Review Board of Chiba University Hospital
1-8-1 inohana chuo-ku chiba city Chiba
043-222-7171
prc-jim@chiba-u.jp
NO
2023 | Year | 06 | Month | 07 | Day |
Unpublished
1800
No longer recruiting
2023 | Year | 03 | Month | 09 | Day |
2023 | Year | 04 | Month | 17 | Day |
2023 | Year | 06 | Month | 02 | Day |
2023 | Year | 09 | Month | 30 | Day |
2023 | Year | 09 | Month | 30 | Day |
2023 | Year | 06 | Month | 07 | Day |
2023 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057995
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |